Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

The FDA flagged Horizon Pharmaceuticals for failure to follow sanitation procedures, insufficient investigations into customer complaints and inadequate reviews of product discrepancies, among other issues.

The agency issued a Form 483 after an inspection in late July and early August revealed that Horizon’s facility in Riviera Beach, Florida failed to follow proper procedures to prevent microbiological contamination of sterile drug products.

The firm also failed to thoroughly review unexplained discrepancies or batch failures. An investigation into certain out-of-specification results lacked an evaluation of equipment and a water analysis.

Four complaints received in 2016 about the firm’s product, TheraTears, were also inadequately investigated. The complaints stemmed from eye irritation allegedly caused by a batch of the eye lubricant. The firm failed to expand the scope of the investigation when necessary, the agency said.

The investigator also found that the facility lacked appropriate controls to ensure that changes in records were only initiated by authorized personnel. The firm’s annual quality standards record evaluation lacked a complete review of complaint and investigation records for each drug product. Specifically, the 22 complaints received about TheraTears in 2016 were not captured in any annual product review.

Lastly, the facility failed to follow established laboratory control procedures. A text file was found on the desktop of a laboratory computer with a username and password allowing unrestricted system access. A chemist in the lab was found to have accessed the system as an administrator by using the information in the text file.